FDAClass IISeptember 9, 2015

LAPAROTOMY PK 4/CS Used by medical staff to perform recall

LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…

Why was LAPAROTOMY PK 4/CS Used by medical staff to perform recalled?

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Code:900149 Lots: 140814945 exp. 10/31/16 140814945 exp. 10/31/16 141015802 exp. 11/30/15 141216410 exp. 1/31/16 141216410 exp. 1/31/16 150217444 exp. 2/28/16 150217446 exp. 2/28/16 150217445 exp. 2/28/16 150217445 exp. 2/28/16 150317607 exp. 3/31/16 150317605 exp. 3/31/16 150317606 exp. 3/31/16 150317608 exp. 3/31/16 150317609 exp. 3/31/16

Product
LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
Recalling firm
Customed, Inc
Quantity
1072
Distribution
Distributed Only in Puerto Rico.
Recall date
September 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls